Document: leaflet MAH GENERIC_PL 02848-0207 change

• leaflet MAH GENERIC_PL 01502-0059
• leaflet MAH GENERIC_PL 02848-0207
• leaflet MAH GENERIC_PL 20075-0080

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MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Midazolam 1mg/ml Solution for Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or nurse.

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

This product will be referred to as Midazolam Injection from here on. What is in this leaflet:

1.    What Midazolam Injection is and what it is used for

2.    What you need to know before you use Midazolam

3.    Howto use Midazolam

4.    Possible side effects

5.    How to store Midazolam

6.    Contents of the pack and other information

1. WHAT MIDAZOLAM INJECTION IS AND WHAT IT IS USED FOR

Midazolam belongs to a group of medicines called benzodiazepines which can cause sedation (sleepiness) and relieve anxiety. It is used:

•    to sedate patients during minor surgical and dental operations, and medical procedures such as passing a tube into the stomach or bladder

•    as an anaesthetic in high risk and elderly patients

•    to sedate patients in intensive care unit

•    by injection into a muscle to provide pre medication for some patients prior to surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MIDAZOLAM

Do not use Midazolam Injection if you are allergic to Midazolam (or any other similar benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6).

Speak to your doctor if this applies to you before you are given this medicine.

Children and babies:

•    if your child is going to be given this medicine

•    it is particularly important to tell your doctor or nurse if your child has cardiovascular disease (heart problems). Your child will be carefully monitored and the dose will be adjusted specially

•    children must be carefully monitored. For infants and babies under 6 months of age this will include monitoring of breathing and oxygen levels.

Warnings and precautions

Talk to your doctor or pharmacist before being given Midazolam Injection if:

•    you are over 60 years of age

•    you suffer from a lung or breathing disorder

•    you have a problem with your kidneys or liver

•    you are debilitated (have an illness that makes you feel very weak, run down and short of energy)

•    you have ever been diagnosed as suffering from a personality disorder

■ you regularly drink large amounts of alcohol or you have had problems with alcohol use in the past

•    you regularly take recreational drugs or you have had problems with drug use in the past

•    you are pregnant or think you may be pregnant (see "Pregnancy and breast-feeding")

•    you suffer from a condition called myasthenia gravis (which causes severe weakness of the muscles)

•    you suffer from heart disease or you have an abnormally low volume of blood in the circulation (due, for example, to haemorrhage, dehydration or severe burns).

Speak to your doctor if one of these applies to you before you are given this medicine.

Other medicines and Midazolam Injection:

Tell your doctor or nurse if you are taking, have recently taken used or might take any other medicines. This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following:

•    strong pain relievers, such as codeine or pethidine

•    diltiazem, nifedipine or verapamil (used for angina or high blood pressure, verapamil may also be used to control irregular heartbeats)

•    medicines to treat high blood pressure like minoxidil, moxonidine, sodium nitroprusside, hydralazine, calcium channel blockers, beta blockers, alpha blockers and ACE inhibitors

•    medicines known as water pills or diuretics

•    the anti-fungal medicines ketoconazole, voriconazole, fluconazole, posaconazole or itraconazole

•    erythromycin, roxithromycin, clarithromycin, quinupristin/dalfopristin and telithomycin (macrolide antibiotics)

•    any other benzodiazepine drugs, such as diazepam or temazepam

•    hypnotics (medicines that make you sleep)

•    sedatives (medicines that make you feel calm or sleepy)

•    antidepressants (medicines for treatment of depression)

•    medicines for epilepsy (fits) such as phenytoin and carbamazepine

•    antihistamines (used to treat allergies)

•    medicines used in HIV infections called protease inhibitors (such as saquinavir) and efavirenz

•    atorvastatin (used to treat high cholesterol levels in blood)

•    rifampicin fused to treat mycobacterial infections such as tuberculosis)

•    herbal medicine St John's Wort

•    ciclosporin used to suppress the immune system

•    medicines used to treat cancer such as nilotinib

•    medicines effective against vomiting and nausea, such as nabilone.

If you are already taking one of these medicines, speak to your doctor before you receive Midazolam Injection. Operations

If you are going to have an inhaled anaesthetic (one that you breath in) for an operation or for dental treatment, it is important to tell your doctor or dentist that you have been given this medicine.

Midazolam Injection with food, drink and alcohol

Do not drink alcohol if you have been given midazolam injection. This is because alcohol can increase the sedative effect of midazolam injection and may cause problems with your breathing.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breastfeeding. Normally, you should not be given this medicine. However, in some circumstances during late pregnancy or labour your doctor may decide it is necessary to give you this injection. This may affect your baby and any concerns should be discussed with your doctor before you are given this injection.

Do not breast-feed for 24 hours after being given midazolam injection. This is because midazolam may pass into your breast milk.

Driving and using machines

Midazolam Injection will affect your ability to drive and operate machinery. You should speak to your doctor for advice on when you will be able to drive, operate machines or resume normal activities.

Midazolam injection may make you sleepy, forgetful or affect your concentration and co-ordination. This may affect your performance at skilled tasks such as driving or using machines.

You should always be taken home by a responsible adult after your treatment, if you have received midazolam injection. The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    do not drive while taking this medicine until you know how it affects you

•    it is an offence to drive if this medicine affects your ability to drive

•    however, you would not be committing an offence if:

-    the medicine has been prescribed to treat a medical or dental problem and

-    you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    it was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is sale for you to drive while taking this medicine.

Midazolam Injection contains Sodium

This medicinal product contains 3.542 mg sodium in 1ml. This means that it is essentially sodium free unless the dose exceeds 6.5ml at a time. Discuss this with your doctor if you are on a controlled sodium diet.

3. HOWTO USE MIDAZOLAM INJECTION

Midazolam Injection may be administered by intravenous injection (injection into a vein) or by intravenous infusion (given by a drip into a vein).

Your doctor will decide on the dose to be given based on the particular procedure they are doing, the degree of sleep (sedation) required, your weight and your response to the medication.

Severe problems with heart and breathing are most likely to occur when the injection is given too rapidly or when too high dose is used.

If you think you have been given more Midazolam Injection than you should have.

This is unlikely as your injection will be administered by a doctor or nurse. If you are concerned about the dose, discuss it with your doctor.

If you are accidentally given too much midazolam injection you may feel drowsy, lose your co-ordination (ataxia) and reflexes, have problems with your speech (dysarthria), have involuntary eye movements (nystagmus), develop low blood pressure (hypotension), stop breathing (apnoea) and suffer cardiorespiratory depression (slowed or stopped breathing and heart beat) and coma.

If the Midazolam injection is no longer given to you:

• If you are given midazolam injection for a long time you may:

-    become tolerant to it. The medicine becomes less effective and does not work as well for you

-    become dependent upon this medicine and get withdrawal symptoms (see below).

Your doctor will reduce your dose gradually to avoid these effects happening to you.

Withdrawal symptoms:

Benzodiazepine medicines, like midazolam injection, may make you dependent if used for a long time. This means that if you stop treatment suddenly, or lower the dose too quickly, you may get withdrawal symptoms. The symptoms can include: headache; muscle pain; feeling very worried (anxious), tense, restless, confused or bad-tempered (irritable); problems with sleeping (insomnia); mood changes; hallucinations (seeing and possibly hearing things that are not there); fits (convulsions).

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side-effects, although not everyone gets them.

Stop having midazolam injection and see your doctor straight away if you notice any of the following side effects. They

can be life threatening and you may need urgent medical treatment:

•    anaphylactic shock (a life threatening allergic reaction). Signs may include a sudden rash, itching or lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body. You may have shortness of breath, wheezing or troubled breathing

•    heart attack (cardiac arrest). Signs may include chest pain which may spread to your neck and shoulders and down your left arm

•    breathing problems or complications (sometimes causing the breathing to stop)

•    choking and sudden blockage of the airway (laryngospasm).

Life threatening side effects are more likely to occur in adults over 60 years of age and those who already have

breathing difficulties or heart problems, particularly if the injection is given too fast or at a high dose.

Other possible side effects:

The following side effects have been reported since the marketing of midazolam but the frequency for them to occur is

not known (frequency cannot be estimated from the available data):

Older people:

• older patients taking benzodiazepine medicines have a higher risk of falling and breaking bones Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MIDAZOLAM INJECTION

Do not use after the expiry date shown on the ampoule and carton.

Keep the ampoules (small bottles) in the outer carton in order to protect from light.

Do not store above 25°C.

Do not use the ampoule if it is damaged or the contents are discoloured.

Keep this medicine out of the sight and reach of children.

If only part used, discard the remaining solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is midazolam.

The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What Midazolam Injection looks like and contents of pack

Midazolam Injection 1 mg in 1 ml is a clear, colourless or slightly yellow, sterile solution contained in clear glass ampoules (small bottles). Each 1ml of this solution contains 1mg of midazolam.

The injection is available in packs of 10 ampoules containing 2ml or 5ml of solution.

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Manufacturer

B. Braun Melsungen AG, Mistelweg 2,12357 Berlin, Germany.

This leaflet was last revised in September 2015.